Surgical delivery device and method of use

ABSTRACT

A delivery device for a stented heart valve comprises a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e)(1) to U.S.Provisional Patent Application Ser. Nos. 61/238,063, filed Aug. 28,2009; 61/287,030, filed Dec. 16, 2009; and 61/322,486, filed Apr. 9,2010; the entire teachings of each of which are incorporated herein byreference.

FIELD

The present disclosure is generally directed to a surgical deliverydevice and method of use. More particularly, the present disclosure isdirected to a surgical delivery device for delivering a stented heartvalve to an implantation site.

BACKGROUND

Heart valve replacement is required when a patient's heart valve becomesdiseased or damaged. Surgically implanted heart valve prostheses haveextended the life expectancy of many patients with defective heartvalves. Such prostheses can be either mechanical or biological (tissuevalves), stented or stentless, and may be implanted into an aortic,mitral, tricuspid, or pulmonary position.

During a surgical procedure, the heart is typically stopped and thepatient attached to a heart/lung bypass machine that pumps andoxygenates the patient's blood. The longer a patient is required to relyon the artificial heart/lung bypass machine to maintain vital functions,the greater the stress on the patient. There is consequently a need tosimplify the surgical implantation of a heart valve prosthesis into theimplantation annulus in order to minimize both the length of surgery andthe amount of time spent on heart/lung bypass.

Stented heart valves made from flexible material or from materials thatexhibit shape memory characteristics promise less complicated and fastervalve implantation procedures. The stents supporting the heart valvesare generally cylindrical in shape and are structured to be crimped soas to reduce their size for delivery to a target site. The stents may beeither self-expanding or non self-expanding. Self-expanding stents maybe formed from any suitable shape memory material, such as Nitinol. Nonself-expanding stents are typically expanded via an inflation means ormechanical expansion means. Stented heart valves are sometimes referredto as suture-less valves because they may be implanted and secured intothe annulus without the use of sutures.

As appreciated by those of ordinary skill in the art, it is desirable tocrimp or otherwise radially compress the stent in a substantiallyuniform manner to minimize the variation in pressures applied to thestent. Such pressure variations may lead to deformation of the stent,which may reduce the ability of the stent to securely maintain the heartvalve at the target location. Thus, if a stent is crimped in anon-uniform manner, it is typically either re-crimped or thrown away.Re-crimping of stents is not desirable because the repeated applicationof force on the stent may cause fatigue or weakening of the stentstructure. Disposing of poorly crimped stents is also not desirable dueto the increased costs associated with the waste. This is especiallytrue with stented heart valves because the stent and the heart valve areattached together and must be disposed of as a single unit.

A number of different strategies have been used to repair or replace adefective heart valve with a stented replacement valve. Generallyspeaking, open-heart valve repair or replacement surgery involves agross thoracotomy, usually in the form of a median sternotomy. In thisprocedure, a saw or other cutting instrument is used to cut the sternumlongitudinally and the two opposing halves of the anterior or ventralportion of the rib cage are spread apart. A large opening into thethoracic cavity is thus created, through which the surgeon may directlyvisualize and operate upon the heart and other thoracic contents. Thepatient must be placed on cardiopulmonary bypass for the duration of thesurgery. Open-chest valve replacement surgery has the benefit ofpermitting the direct implantation of the replacement valve at itsintended target site. For example, the crimped stented replacement valvemay be delivered to the target site with a delivery catheter or thelike. Once positioned in the desired location, the stent may bere-expanded or self-expands to secure the replacement heart valve inplace by exerting radial forces against the internal walls of theimplantation annulus.

New delivery devices and methods which make the surgical procedure moreefficient and minimize the length of time of the procedure are alwaysneeded. Furthermore, new delivery devices and methods which provide thesurgeon with improved visualization of the stented heart valve duringdelivery as well as improved control over the deployment of the stentedheart valve are also needed.

SUMMARY

The present disclosure addresses the foregoing needs by providing anovel delivery device for a stented heart valve including a handle, anelongate shaft extending from a distal end of the handle, and a conicalhousing having a proximal end coupled to the elongate shaft and an opendistal end, the conical housing having a conical lumen therein with afirst internal diameter adjacent to the proximal end of the conicalhousing and a larger second internal diameter adjacent to the opendistal end of the conical housing.

In accordance with another aspect of the present disclosure, a novelmethod of loading a stented heart valve into a delivery device includesthe steps of receiving a delivery device having a handle on a proximalend, a housing on a distal end, and a shaft extending therebetween,crimping a stented heart valve with a crimping tool, pushing the crimpedstented heart valve into the housing of the delivery device, pulling acontrol suture of the stented heart valve through the shaft and thehandle of the delivery device, and engaging the control suture with anengagement mechanism operably coupled to the handle of the deliverydevice to apply tension to the control suture such that the crimpedstented heart valve is retained within the housing.

In accordance with another aspect of the present disclosure, a novelmethod of delivering a stented heart valve to an implantation siteincludes the steps of receiving a delivery device including a conicalhousing, the conical housing having a conical lumen therein with a firstinternal diameter adjacent to a proximal end of the conical housing anda larger second internal diameter adjacent to a distal end of theconical housing, loading a crimped stented heart valve into the conicalhousing such that an inflow end of the stented heart valve extendsoutside of the housing past the distal end, positioning the conicalhousing at an implantation site, allowing the inflow end of the stentedheart valve to expand within the implantation site, and manipulating thedelivery device to expose additional portions of the stented heart valveto allow for expansion within the implantation site.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a crimping tool in accordance with thepresent disclosure.

FIG. 2 is an exploded perspective view of the crimping tool of FIG. 1.

FIGS. 3A and 3B are front and back views, respectively, of the crimpingtool of FIG. 1 illustrating a compression assembly in an uncrimpedposition.

FIGS. 4A and 4B are front and back views, respectively, of the crimpingtool of FIG. 1 illustrating the compression assembly in a crimpedposition.

FIG. 5 is a front view of the crimping tool of FIG. 1 illustrating adelivery device holder having a seat member aligned with an accessaperture of the crimping tool.

FIGS. 6A-6D are perspective, side, top, and bottom views, respectively,of a compression assembly bar in accordance with the present disclosure.

FIG. 7 is a perspective view of the compression assembly and attacheddrive wheel removed from the crimping tool.

FIG. 8 is another embodiment of a compression assembly bar in accordancewith the present disclosure.

FIG. 9 is another embodiment of a compression assembly bar in accordancewith the present disclosure.

FIG. 10 is another embodiment of a compression assembly bar inaccordance with the present disclosure.

FIGS. 11A and 11B are front and back views, respectively, of thecrimping tool of FIG. 1 with a front plate removed to illustratemovement of the compression assembly.

FIGS. 12A and 12B are perspective and side views, respectively, of astented heart valve that may be crimped and delivered to a patient inaccordance with the present disclosure.

FIGS. 13A and 13B are perspective and side views, respectively, of adelivery device in accordance with the present disclosure.

FIGS. 14A and 14B are diagrams illustrating the operation of a deliverydevice engagement mechanism in accordance with the present disclosure.

FIG. 15 is a perspective view of an engagement mechanism retentionassembly in accordance with the present disclosure.

FIGS. 16A and 16B are diagrams illustrating the operation of theengagement mechanism retention assembly.

FIG. 17 is a side view of a stylet tool that may be used with thedelivery device of the present disclosure.

FIG. 18 is a perspective view of the crimping tool with the stentedheart valve loaded therein.

FIG. 19 is a perspective view of the crimping tool after the stentedheart valve has been crimped.

FIG. 20 is a perspective view of the delivery device aligned with thecrimping tool.

FIG. 21 is a perspective view of the delivery device positioned withinthe delivery device holder of the crimping tool.

FIG. 22 is a perspective view of the compression assembly illustrating aplurality of recesses forming a stepped region for engagement with thedelivery device.

FIG. 23 is a perspective view of the crimping tool illustrating thecrimped stented heart valve being loaded into the delivery device.

FIG. 24 is a diagram illustrating a control suture of the stented heartvalve engaged by the engagement mechanism.

FIG. 25 is a perspective view of the delivery device with the stentedheart valve hanging from a distal end thereof.

FIG. 26 is a perspective view of the delivery device with the crimpedstented heart valve loaded therein and ready for delivery to a patient.

FIGS. 27A-27C are diagrams illustrating a method of delivering a stentedheart valve to an aortic annulus in accordance with the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure is generally directed to devices and methods forreducing the size of a stented heart valve and delivering the stentedheart valve to an implantation site for deployment within a patient. Insome embodiments described in detail herein, a stented heart valve maybe crimped using a crimping tool, loaded into a delivery device, anddeployed within a patient implantation site in a controlled manner.

As will be appreciated by those of ordinary skill in the art, thestented heart valve may be crimped or radially compressed in anysuitable manner prior to loading the heart valve into the deliverydevice. Thus, the specific crimping tool embodiments set forth hereinare provided merely for purposes of example and not limitation.

FIG. 1 is a perspective view of one embodiment of a crimping tool 10that may be utilized with the present disclosure. As illustrated in FIG.1, the crimping tool 10 generally includes a compression assembly 12disposed within a housing 14, an actuation lever 16, a lever lock 18,and a delivery device holder 20. The housing 14 includes an elongatedbase portion 21 that is sized and structured to provide sufficientsupport and stability to the crimping tool 10 during use. As will beappreciated by those of ordinary skill in the art, the base portion 21of the housing 14 may be positioned on or attached to a table or othersupport surface during use of the crimping tool 10. In alternativeembodiments, the base portion 21 may be a separate structure that iscoupled to the housing 14 instead of being formed integral therewith.

As illustrated in FIG. 1, the housing 14 of the crimping tool 10includes a front wall or plate 22 and a back wall or plate 23 coupledtogether in a spaced apart relationship so as to define an opening 25therebetween. The compression assembly 12 is disposed between the frontplate 22 and the back plate 23 and is operably coupled to the actuationlever 16 such that the actuation lever 16 extends through the opening25. As will be discussed in further detail to follow, movement of theactuation lever in the directions indicated by arrows 24A and 24Bcontrols movement of the compression assembly 12 between an uncrimpedposition and a crimped position, respectively. The actuation lever 16 ofFIG. 1 is designed for manual operation by an operator, such as bygrasping and moving the actuator 16 by hand. However, alternativeembodiments of the crimping tool 10 may include actuation levers thatare operated via alternative mechanical, electrical, hydraulic,electromechanical, or computer-controlled actuation means withoutdeparting from the intended scope of the present disclosure.

The housing 14 of the crimping tool 10 is described as being formed bytwo spaced apart plates that are coupled together so as to form anopening therebetween merely for purposes of example and not limitation.Thus, numerous other housing configurations may be used as will beappreciated by those of ordinary skill in the art. In one alternativeembodiment, the housing 14 may instead be formed as a rear housingportion having a cavity that is structured to receive the compressionassembly 12 and a cover plate that may be coupled to the rear housingportion such that the compression assembly 12 is substantially enclosedtherein. Furthermore, the housing 14 may be constructed using anysuitable materials including, but not limited to, various metals orplastics.

Although not a necessary component of the present disclosure, the leverlock 18 is hingedly coupled to the housing 14 and operable to lock theactuation lever 16 when the compression assembly 12 is in the crimpedposition. As illustrated in FIG. 1, the lever lock 18 “blocks” movementof the actuation lever 16 in the direction indicated by arrow 24Athereby preventing unintentional expansion of the compression assembly12 and the stent (not shown) positioned therein from the crimpedposition back toward the uncrimped position. As discussed above,repeated cycles of compression and expansion of a stent may lead tofatigue or weakening of the stent structure. Thus, the lever lock 18 maybe used to ensure that the stent is only crimped a single time prior todelivery to a patient.

The delivery device holder 20 is structured to engage a delivery deviceand align the delivery device with an access aperture 26 in the frontplate 22 of the housing 14 that is sized to allow a stent (not shown) tobe passed therethrough and into the compression assembly 12 forcrimping. This alignment allows the crimped stent to be loaded into thedelivery device for subsequent delivery to a patient. More particularly,as illustrated in FIG. 1 the delivery device holder 20 includes asliding plate 17 having a seat member 19 that is structured to mate withor engage the delivery device. As will be appreciated by those ofordinary skill in the art, the structure and contour of the seat member19 may vary depending upon the type of delivery device that is beingsupported. The sliding plate 17 and the seat member 19 are illustratedin FIG. 1 as separate components that are coupled together with asuitable fastening means such as a fastener 15. Alternatively, thesliding plate 17 and the seat member 19 may be formed as a single,integral unit.

The sliding plate 17 is slidably coupled to the front plate 22 of thehousing 14 via at least one engagement member 27 positioned within acorresponding horizontal slot 28. The delivery device holder 20 isstructured for movement in the direction indicated by arrow 35 from afirst position as illustrated in FIG. 1 wherein the seat member 19 isnot aligned with a center axis of the access aperture 26 to a secondposition wherein the seat member 19 is substantially aligned with thecenter axis of the access aperture 26. The range of movement of thedelivery device holder 20 is determined by the length of the horizontalslot 28 in the sliding plate 17.

The delivery device holder 20 of FIG. 1 is illustrated as including twoengagement members 27 and two corresponding horizontal slots 28 merelyfor purposes of example and not limitation. Those of ordinary skill inthe art will appreciate that any number of engagement members andcorresponding slots may be used without departing form the intendedscope of the present disclosure.

FIG. 2 is an exploded perspective view of the crimping tool 10 ofFIG. 1. As illustrated in FIG. 2, the crimping tool 10 further includesa drive wheel 29 that, along with the compression assembly 12, isstructured to be positioned between the front plate 22 and the backplate 23 of the housing 14. The drive wheel 29 is a generallycylindrical structure with an open center portion, thereby resembling arim or ring member. The drive wheel 29 is rotatable with respect to thehousing 14 and operably coupled to the compression assembly 12 to drivemovement of the compression assembly 12 during the crimping process. Aswill be appreciated by those of ordinary skill in the art, the frontplate 22 and the back plate 23 are spaced sufficiently apart whenassembled (FIG. 1) such that the drive wheel 29 and attached compressionassembly 12 may freely rotate therebetween. The actuation lever 16 isdesigned to operably engage the drive wheel 29 to initiate and controlthe movement of the drive wheel 29. As will be appreciated by those ofordinary skill in the art, the actuation lever 16 may be coupled to thedrive wheel 29 in any suitable manner, or alternatively may be formedintegral with the drive wheel 29.

With the crimping tool 10 illustrated in FIG. 2, the front plate 22 isattachable to the back plate 23 with a plurality of fasteners 30 thatare structured to be passed though corresponding pluralities ofapertures 31 in the front plate 22, elongate spacer elements 32positioned between the front plate 22 and the back plate 23, andapertures 33 in the back plate 23. The fasteners 30 may have externalthreads that are structured to engage with internal threads of theapertures 31 in the front plate 22 and/or the apertures 33 in the backplate 23. As will be appreciated by those of ordinary skill in the art,numerous other means for attaching the front plate 22 to the back plate23 of the housing 14 are contemplated and within the intended scope ofthe present disclosure including, but not limited to, rivets, welding,an adhesive, or the like. Thus, threaded fasteners are described andillustrated merely for purposes of example and not limitation.

As illustrated in FIG. 2, the compression assembly 12 includes aplurality of bars 34, a plurality of drive pins 36, and a plurality ofguide pins 38. The drive pins 36 and guide pins 38 are preferablymetallic and generally cylindrical in shape, although the pins may beconstructed in various other shapes and from various other materialswithout departing from the intended scope of the present disclosure.Each of the bars 34 includes a generally cylindrical drive pin slot 40structured to receive one of the drive pins 36 and a generallycylindrical guide pin slot 42 structured to receive one of the guidepins 38. The drive wheel 29 includes a plurality of generallycylindrical drive wheel slots 44 that are structured to receive thedrive pins 36 to operably couple the drive wheel 29 to the plurality ofbars 34 of the compression assembly 12. The drive pin slots 40 and/orthe drive wheel slots 44 may be sized such that they have a diameterthat is slightly larger than the diameter of the drive pins 36 to allowthe bars 34 to rotate or pivot with respect to the drive wheel 29 as thedrive wheel is rotated with the actuation lever 16. The guide pin slots42 may be sized similar to the guide pins 38 such that a friction fit isformed therebetween, or alternatively the guide pin slots 42 may besized larger than the guide pins 38 to allow for slight rotation of thedistal end of the bars 34.

The crimping tool 10 is described and illustrated herein as including asingle plurality of drive pins 36 and a single plurality of guide pins38 merely for purposes of example and not limitation. In alternativeembodiments, the compression assembly 12 may include a first pluralityof drive pins structured to extend from the drive wheel slots 44 towardthe front side of the bars 34 adjacent the front plate 22 and a secondplurality of drive pins structured to extend from an opposite end of thedrive wheel slots 44 toward the back side of the bars 34 adjacent theback plate 23. Similarly, the compression assembly 12 may include afirst plurality of guide pins structured to extend from the guide pinslots 42 in the bars 34 toward the front plate 22 and a second pluralityof guide pins structured to extend from an opposite end of the drive pinslots 42 in the bars 34 toward the back plate 23.

The drive wheel slots 44 may be substantially equally spaced around thecircumference of the drive wheel 29. Furthermore, as illustrated in FIG.2 the number of drive wheel slots 44 is equal to the number of bars 34in the compression assembly 12. Thus, each bar 34 includes one drive pinslot 40, one guide pin slot 42, and is associated with one drive wheelslot 44 in the drive wheel 29. With embodiments in which the drive wheelslots 44 are equally spaced around the circumference of the drive wheel29, the bars 34 are also equally spaced around the circumference of thedrive wheel 29 in a spoke-like fashion.

As will be described in further detail to follow, the bars 34 arearranged to form a generally circular or polygonal chamber 50 that isstructured to receive a stent (not shown) or other element to becrimped. With the stent positioned within the chamber 50, the internaldimensions of the chamber 50 may be reduced by manipulating theactuation lever 16 as previously discussed, thereby moving thecompression assembly 12 from an uncrimped position to a crimpedposition. The extent to which the dimensions of the chamber 50 arereduced, and thus the amount of crimping, may be controlled by theposition of the actuation lever 16. In the embodiment of the crimpingtool 10 illustrated herein, the actuation lever 16 moves in a clockwisedirection during the crimping process. However, those of ordinary skillin the art will appreciate that the compression assembly 12 may bemodified such that the actuation lever 16 instead moves in acounter-clockwise direction during the crimping process.

FIGS. 3A and 3B are front and back views, respectively, of the crimpingtool 10 in accordance with the present disclosure. As illustrated inFIG. 3A, the front plate 22 of the housing 14 includes a first pluralityof radially extending elongate slots 52. Similarly, as illustrated inFIG. 3B, the back plate 23 of the housing 14 includes a second pluralityof radially extending elongate slots 54 that are aligned with the firstplurality of elongate slots 52. When assembled, each of the guide pins38 is structured to pass through a corresponding guide pin slot 42 inone of the bars 34 as previously discussed. Additionally, each of theguide pins 38 is designed with a length that is sufficient to allow afirst end of the guide pin 38 to extend into a corresponding one of theelongate slots 52 in the front plate 22 and a second end of the guidepin 38 to extend into a corresponding one of the elongate slots 54 inthe back plate 23. As will be appreciated by those of ordinary skill inthe art, the elongate slots 52 and 54 are structured and sized to allowa predetermined amount of radial movement of the guide pins 38 andattached bars 34 during the crimping process to alter the dimensions ofthe chamber 50.

In the state of FIGS. 3A and 3B, the compression assembly 12 is in an“uncrimped” position. FIGS. 4A and 4B are front and back views,respectively, of the crimping tool 10 illustrating the compressionassembly 12 in a “crimped” position. As will be appreciated by those ofordinary skill in the art, the uncrimped position of FIGS. 3A and 3B andthe crimped position of FIGS. 4A and 4B represent the two endpoints ofthe crimping range. Depending upon the size of the stent (not shown) andthe amount of crimping that is desired, an operator may achieve adesirable amount of crimping without actuating the compression assembly12 to the fully crimped position of FIGS. 4A and 4B.

With reference again to the uncrimped position of FIG. 3A, the chamber50 is defined by a first internal dimension D1, which may approximatelyrepresent the diameter of a circle. When the chamber 50 is in theuncrimped position, each of the guide pins 38 is positionedsubstantially adjacent to a first end 56 of a corresponding elongateslot 52 in the front plate 22 as illustrated in FIG. 3A and a first end58 of a corresponding elongate slot 54 in the back plate 23 asillustrated in FIG. 3B. In order to commence the crimping process todecrease the internal diameter D1 of the chamber 50, the operator maymove the actuation lever 16 in the direction indicated by arrow 24B.

As illustrated in the crimped position of FIG. 4A, the chamber 50 isdefined by a reduced second internal dimension D2, which may alsoapproximately represent the diameter of a circle. As will be appreciatedby those of ordinary skill in the art, a center axis of the chamber 50corresponds with the center axis of the access aperture 26. When thechamber 50 is in the crimped position, each of the guide pins 38 ispositioned substantially adjacent to a second end 60 of a correspondingelongate slot 52 in the front plate 22 as illustrated in FIG. 4A and asecond end 62 of a corresponding elongate slot 54 in the back plate 23as illustrated in FIG. 4B. As the chamber 50 contracts and becomessmaller, the internal surface defining the chamber 50 moves toward thecenter axis of the chamber 50 in a substantially uniform manner suchthat the chamber maintains a substantially circular configurationthroughout the crimping process. This uniform compression is the resultof the interaction between the bars 34, the drive pins 36, the guidepins 38, and the elongate slots 52 and 54 in the housing 14.

More specifically, during the crimping process, movement of theactuation lever 16 in the clockwise direction 24B causes the drive wheel29 to also move in the clockwise direction. Because the bars 34 of thecompression assembly 12 are operably coupled to the drive wheel 29 withthe drive pins 36 at a proximal end, the proximal ends of the bars 34are caused to rotate clockwise along with the drive wheel 29. Asdiscussed above, in order to allow movement of the bars 34 relative toone another to adjust the size of the chamber 50, the drive pins 36,drive pin slots 40, and drive wheel slots 44 are sized such that thebars 34 are rotatable or pivotable with respect to the drive wheel 29along an axis through the drive pins 36. However, the distal ends of thebars 34 are constrained from any substantial amount of rotation due tothe engagement of the guide pins 38 with the elongate slots 52 in thefront plate 22 and the elongate slots 54 in the back plate 23. As aresult, the guide pins 38 are allowed to slide inward along the radiallyextending elongate guide slots 52 and 54 to reduce the internal diameterof the chamber 50.

As will be appreciated by those of ordinary skill in the art, anyradially compressible stent having a diameter in the expanded state thatis greater than D2 but less than D1 may be crimped with the crimpingtool 10 of the present disclosure. Furthermore, the size of the chamber50 in the uncrimped and crimped positions may be modified by changing,for example, the number, size, or shape of the bars 34 of thecompression assembly 12.

As illustrated in FIGS. 3A and 4A, the delivery device holder 20 islocated in the first position wherein the seat member 19 is not alignedwith the center axis of the access aperture 26. Once the stent (notshown) or other device has been crimped within the chamber 50, the seatmember 19 of the delivery device holder 20 may be substantially alignedwith the center axis of the access aperture 26 by moving the slidingplate 17 to the position illustrated in FIG. 5. With the seat member 19of the delivery device holder 20 substantially aligned with the centeraxis of the access aperture 26, the crimped stent may be easily loadedinto the delivery device (not shown) for subsequent deployment within apatient.

In the embodiment of the delivery device holder 20 illustrated herein,the engagement members 27 are externally threaded fasteners that arestructured to threadably engage apertures in the front plate 22 of thehousing 14. More particularly, the engagement members 27 are movablefrom a locked position wherein a compression force is applied to thesliding plate 17 to maintain its position relative to the front plate 22of the housing 14, to an unlocked position wherein the compression forceis released and the sliding plate 17 is movable relative to the frontplate 22. Prior to commencing movement of the sliding plate 17, theengagement members 27 are first rotated in a counter-clockwise direction51A as illustrated in FIG. 4A. Rotating the engagement members 27 insuch a manner releases the compression force applied to the slidingplate 17. After releasing the compression force by moving the engagementmembers 27 from the locked to the unlocked position, the delivery deviceholder 20 may be slid to the position illustrated in FIG. 5 tosubstantially align the seat member 19 with the center axis of theaccess aperture 26. Once the seat member 19 has been properly aligned,the engagement members 27 may be rotated in a clockwise direction 51B asillustrated in FIG. 5 to prevent subsequent movement of the deliverydevice holder 20 relative to the front plate 22 of the housing 14.

Although movement of the delivery device holder 20 has been described asoccurring after the compression assembly 12 has been actuated to thecrimped position, those of ordinary skill in the art will appreciatethat the seat member 19 may be aligned with the center axis of theaccess aperture 26 at any time without departing from the intended scopeof the present disclosure. For example, the seat member 19 of thedelivery device holder 20 may be aligned with the center axis of theaccess aperture 26 prior to actuating the actuation lever 16 to commencethe crimping process.

FIGS. 6A-6D are perspective, side, top, and bottom views, respectively,of one of the bars 34 in accordance with the present disclosure. Asillustrated in FIGS. 6A-6D, the bar 34 includes a proximal end 53, adistal end 55, a front face 70, a back face 72, a first side face 74, asecond side face 76, and a chamfered leading edge 78. The first andsecond side faces 74 and 76 are substantially straight or planarsurfaces that are generally parallel to one another. The second sideface 76 opposes and intersects the chamfered leading edge 78 near thedistal end 55. As further illustrated in FIGS. 6A-6D, a proximal portionof the bar 34 comprises a front leg 80A and a back leg 80B separated bya proximal opening 82 that is sized similar to or slightly larger than awidth of the drive wheel 29. In the illustrated embodiment, the drivepin slot 40 extends through both the front leg 80A and the back leg 80B.However, in alternative embodiments, the drive pin slot 40 may extendcompletely through either the front leg 80A or the back leg 80B and onlypartially through the other of the front leg 80A or the back leg 80B aswill be appreciated by those of ordinary skill in the art.

Although the distal end 55 is illustrated as comprising a substantiallyflat chamfered leading edge 78, the leading edge 78 may alternatively bestructured with a non-flat, curvilinear, and/or rounded surface withoutdeparting from the intended scope of the present disclosure.

As illustrated in FIG. 6B, the centers of the drive pin slot 40 and theguide pin slot 42 are substantially aligned with a bar axis A extendingthrough a center plane of the bar 34. However, in alternativeembodiments, the drive pin slot 40 and/or the guide pin slot 42 may beoffset from the bar axis A. As will be appreciated by those of ordinaryskill in the art, offsetting the drive pin slot 40 and/or the guide pinslot 42 may provide additional tolerance for movement of the bars 34through the crimping range of the compression assembly 12.

The bars 34 may be constructed using any suitable material as will beappreciated by those of ordinary skill in the art. Exemplary materialsmay include, but are not limited to, polymeric materials, polycarbonatematerials, thermoplastic materials, ceramic materials, compositematerials, metallic materials, and the like.

FIG. 7 is a perspective view of the compression assembly 12 and thedrive wheel 29 removed from the crimping tool to illustrate thepositioning of the drive wheel 29 relative to the bars 34 of thecompression assembly 12. As illustrated in FIG. 7, the drive wheel 29 isstructured and sized to be positioned within the proximal opening 82between the front leg 80A and the back leg 80B of the bars 34. Aspreviously discussed, the compression assembly 12 is operably coupled tothe drive wheel 29 by inserting the drive pin 36 through the drive pinslot 40 in the front and back legs 80A and 80B and the drive wheel slot44 of the drive wheel 29 positioned therebetween.

FIG. 8 is a side view of an alternative embodiment bar 34A in accordancewith the present disclosure. As illustrated in FIG. 8, the bar 34A issubstantially similar to the bar 34 previously described in detail withreference to FIGS. 6A-6D. However, instead of the drive pin slot 40 andthe guide pin slot 42 of the bar 34A being in substantial alignment withthe bar axis A, the guide pin slot 42 of the bar 34A is offset from thebar axis A. As will be appreciated by those of ordinary skill in theart, the guide pin slot 42 may be offset in either direction, i.e.toward the first side face 74 or the second side face 76, withoutdeparting from the intended scope of the present disclosure.

FIG. 9 is a side view of another alternative embodiment bar 34B inaccordance with the present disclosure. As illustrated in FIG. 9, thebar 34B is substantially similar to the bar 34 previously described indetail with reference to FIGS. 6A-6D. However, instead of the drive pinslot 40 and the guide pin slot 42 of the bar 34B being in substantialalignment with the bar axis A, the drive pin slot 40 of the bar 34B isoffset from the bar axis A. As will be appreciated by those of ordinaryskill in the art, the drive pin slot 40 may be offset in eitherdirection, i.e. toward the first side face 74 or the second side face76, without departing from the intended scope of the present disclosure.

FIG. 10 is a side view of another alternative embodiment bar 34C inaccordance with the present disclosure. As illustrated in FIG. 10, thebar 34C is a “hybrid” of the bar 34A of FIG. 8 and the bar 34B of FIG. 9wherein both the drive pin slot 40 and the guide pin slot 42 are offsetfrom the bar axis A. As will be appreciated by those of ordinary skillin the art, the drive pin slot 40 and the guide pin slot 42 may eitherbe offset on opposite sides of the bar axis A or on the same side of thebar axis A without departing from the intended scope of the presentdisclosure.

FIG. 11A is a front view of the crimping tool 10 with the front plate 22(FIG. 2) removed illustrating the compression assembly 12 in theuncrimped position. As illustrated in FIG. 11A, the bars 34 are equallyspaced around the drive wheel 29 and arranged such that the chamferedleading edge 78 of one bar 34 is slidable upon the second side face 76of an adjacent bar 34 during the crimping process. Further, a perimeterof the chamber 50 is defined by an exposed portion 86 of the second sideface 76 of each of the bars 34.

FIG. 11B is a front view of the crimping tool 10 with the front plate 22(FIG. 2) removed illustrating the compression assembly 12 in the crimpedposition. As illustrated in FIG. 11B, the proximal ends of the bars 34have rotated clockwise by a predetermined amount R relative to theuncrimped position. The distal ends of the bars 34 are constrained fromany substantial amount of rotation due to the interaction of the guidepins 38 with the elongate slots 52 in the front plate 22 and theelongate slots 54 in the back plate 23 as previously discussed. Thus,the distal ends of the bars 34 are guided radially inward along theelongate guide slots 52 and 54 as the chamber 50 is contracted. As willbe appreciated by those of ordinary skill in the art, in the crimpedposition illustrated in FIG. 11B there is a decrease in the size of thechamber 50 perimeter due to a reduction in the exposed portion 86 of thesecond side face 76 of each of the bars 34.

The compression assembly 12 is described and illustrated herein asincluding twelve bars 34. However, the number of bars 34 may be variedas will be appreciated by those of ordinary skill in the art. Forexample, the requisite number of bars 34 may depend upon a diameter ofthe drive wheel 29 or a width of the bars 34 between the first side face74 and the second side face 76. Thus, twelve bars 34 are illustratedmerely for purposes of example and not limitation.

Those of ordinary skill in the art will appreciate that the foregoingexemplary embodiment of a crimping tool is only one type of crimpingtool that may be utilized with the delivery device and method of thepresent disclosure. Any tool that is capable of radially compressing astented heart valve may also be used. One acceptable construction of adelivery device that is used to prepare a stented heart valve fordeployment within a patient, along with its method of use, will now bedescribed. The heart valve delivery device and method in accordance withthe present disclosure allows for the loading and delivery of a radiallycompressible stented heart valve to a desired implantation positionwithin a patient, such as the aortic annulus. The delivery device of thepresent disclosure provides the surgeon with improved visibility whendeploying the stented heart valve within the aortic annulus and allowsthe stented heart valve to be radially deployed in a controlled mannerfor precise anatomical placement.

FIGS. 12A and 12B are perspective and side views, respectively, of astented heart valve 100 that may be crimped from a first enlarged sizedto a second reduced size using the crimping tool 10 (FIG. 1) previouslydescribed. As illustrated in FIGS. 12A and 12B, the stented heart valve100 is a substantially tubular structure having a length L1 between aninflow end 102 and an outflow end 104 and generally includes atri-leaflet replacement valve 106, a support stent 108, and a clothcovering 110 adjacent the inflow end 102. As will be appreciated bythose of ordinary skill in the art, any suitable cloth material may beused such as polyester or the like. The replacement valve 106 isattached to the support stent 108 such that the replacement valve 106resides therein. The support stent 108 is a radially expandable andcollapsible structure adapted to be delivered to an implantation sitesuch as an aortic annulus, and may be formed from any suitable materialincluding, but not limited to, stainless steel or Nitinol.

The support stent 108 has a substantially tubular configuration andincludes a plurality of longitudinally extending support posts 114extending between an inflow rim and an outflow rim of the support stent108. As illustrated in FIGS. 12A and 12B, the support stent 108 includesthree support posts 114 corresponding to the three leaflets of thereplacement valve 106. The replacement valve 106 is secured to thesupport stent 108 by threading a plurality of commissural tabs 116 ofthe replacement valve 106 through slots in the support posts 114.

The replacement valve 106 is illustrated and described as a tri-leafletvalve merely for purposes of example and not limitation. Thus, thestented heart valve 100 may include a replacement valve having anynumber of valve leaflets. However, as will be appreciated by those ofordinary skill in the art, replacement valves having a number ofleaflets other than three will require a modified valve supportstructure.

As further illustrated in FIGS. 12A and 12B, the stented heart valve 100includes a control suture 112 that is sewn into the cloth covering 110.The control suture 112 is threaded through a plurality of sutureapertures 118 in the cloth covering 110. In the embodiment of thestented heart valve 100 illustrated and described herein, one controlsuture 112 is threaded through a total of six suture apertures 118,wherein two suture apertures 118 are formed between each of the threesupport posts 114. However, as will be appreciated by those of ordinaryskill in the art, the number and location of the suture apertures 118may vary without departing from the intended scope of the presentdisclosure so long as a sufficient number of suture apertures areutilized in order to maintain the radially compressed stented heartvalve in the crimped configuration as will be described in detail tofollow. Further, a single control suture 112 is described merely forpurposes of example and not limitation, and any number of additionaldisclosure may be incorporated into the stented heart valve 100 as willbe appreciated by those of ordinary skill in the art.

FIGS. 13A and 13B are perspective and side views, respectively, of adelivery device 130 in accordance with the present disclosure. Asillustrated in FIGS. 13A and 13B, the delivery device 130 generallyincludes a handle 132, an engagement mechanism 133 operably coupled tothe handle 132, an elongate shaft 134, and a cone-shaped housing 136.The elongate shaft 134 is coupled adjacent a proximal end 135 to thehandle 132 and adjacent a distal end 137 to the cone-shaped housing 136.The elongate shaft 134 may be coupled to the handle 132 and thecone-shaped housing 136 via any suitable coupling means including, butnot limited to, a compression fit, a threaded coupling, or an adhesive.

As illustrated in FIGS. 13A and 13B, the cone-shaped housing 136includes a corresponding cone-shaped lumen 138 that is sized andstructured to receive the stented heart valve 100 upon crimping.Although not required, the cone-shaped housing 136 may be made from asuitable transparent material, such as polycarbonate or the like, toallow the surgeon to visualize the correct anatomical placement of thedevice in the aortic annulus. Further, the cone-shaped housing 136 has alength L2 that is slightly less than the length L1 (FIG. 12B) of thestented heart valve 100 (FIG. 12B) to allow exposure of the inflow end102 (FIG. 12B) in the aortic annulus during deployment so that thesurgeon can ensure correct anatomical placement.

As further illustrated in FIG. 13B, a proximal base portion 142 of thecone-shaped housing 136 includes a central passage 144 that isstructured to provide a pathway from the cone-shaped lumen 138 to ashaft lumen 146 extending longitudinally along the length of the shaft134 into the handle 132. When assembled, the central passage 144 in thebase portion 142 is aligned with the shaft lumen 146 to allow thecontrol suture 112 (FIG. 12A) to be received therein. More particularly,and as will be discussed in further detail to follow, the control suture112 is of a sufficient length to extend through the shaft lumen 146 andinto the handle 132 to maintain the radially compressed stented heartvalve in the crimped configuration and allow deployment within theaortic annulus or other implantation position.

The handle 132 of the delivery device 130 includes a handle lumen 148extending from a back side of the handle 132 into an interior thereof.The handle lumen 148 is substantially aligned with the shaft lumen 146of the shaft 134 and the central passage 144 in the cone-shaped housing136. The alignment of the handle lumen 148, the shaft lumen 146, and thecentral passage 144 provides a substantially linear pathway forinsertion of a stylet tool through the handle 132 and into thecone-shaped housing 136 to grasp the control suture 112 and pull thecontrol suture 112 back through the delivery device 130 such that thecontrol suture 112 (FIG. 12A) extends out of the handle lumen 148.

As illustrated in FIGS. 13A and 13B, the handle 132 includes a firsthandle section 147A and a second handle section 147B that are coupledtogether with a suitable fastening means, such as a plurality ofthreaded fasteners 149 structured to threadably engage with acorresponding plurality of threaded apertures in the handle 132. Formingthe handle 132 with two or more sections that are coupled togetherallows for easier assembly of the delivery device 130. Although thefirst and second handle sections 147A and 147B are described as beingcoupled together with a plurality of threaded fasteners, any suitablefastening means may be used including, but not limited to, rivets,bolts, welding, an adhesive, or the like. Thus, threaded fasteners aredescribed merely for purposes of example and not limitation.

The various components of the delivery device 130, including the handle132, the elongate shaft 134, and the cone-shaped housing 136, may bemade of any material that is suitable for use in a surgical device, suchas stainless steel or medical-grade plastics.

FIGS. 14A and 14B are side views of the delivery device 130 with aportion of the handle 132 removed to illustrate the operation of a firstexemplary engagement mechanism 133 in accordance with the presentdisclosure. Particularly, FIG. 14A illustrates the engagement mechanism133 in an “engaged” position while FIG. 14B illustrates the engagementmechanism 133 in a “disengaged” position. As illustrated in FIGS. 14Aand 14B, the engagement mechanism includes a trigger 150 that ispivotally coupled to a pivot pin 152 extending through the trigger 150and connected to the first and second handle sections 147A and 147B. Theengagement mechanism 133 further includes a first elongate gripper 154Acoupled to the trigger 150 and a second elongate gripper 154B coupled tothe handle 132 such that it is stationary. The first and second elongategrippers 154A and 154B are operable to grip the control suture 112 (FIG.12A) as will be hereinafter explained.

As illustrated in FIGS. 14A and 14B, the engagement mechanism 133further includes a torsion spring 156 operably coupling the trigger 150to the housing 132. Those of ordinary skill in the art will appreciatethat the engagement mechanism 133 may include a single torsion spring156 or alternatively multiple torsion springs 156. In one exemplaryembodiment, the engagement mechanism 133 may include a first torsionspring positioned adjacent a first side of the trigger 150 and the firsthandle section 147A and a second torsion spring positioned adjacent asecond side of the trigger 150 and the second handle section 147B.

The torsion spring 156 of FIGS. 14A and 14B includes a first leg 158that is structured to engage the trigger 150 and a second leg 160 thatis structured to engage the handle 132. As will be appreciated by thoseof ordinary skill in the art, the first and second legs 158 and 160anchor the ends of the torsion spring 156 to the trigger 150 and thehousing 132, respectively. The torsion spring 156 is structured to biasthe trigger 150 in the engaged position illustrated in FIG. 14A.

In the engaged position of FIG. 14A, the first and second elongategrippers 154A and 154B are positioned in close proximity or in contactwith one another to substantially block the path from the handle lumen148 to the shaft lumen 146. In effect, the first and second elongategrippers 154A and 154B function as a clamping means for clamping andlocking the control suture 112 (FIG. 12A) within the handle 132 duringthe delivery procedure to maintain the stented heart valve 100 (FIG.12A) in the crimped configuration.

In order to actuate the engagement mechanism 133 to the disengagedposition of FIG. 14B, the surgeon simply pushes down on the trigger 150against the force of the torsion spring 156. Pushing the trigger 150against the force of the torsion spring 156 will cause the spring tobecome “loaded” or compressed. In the disengaged position, the first andsecond elongate grippers 154A and 154B are separated from one anotherand the control suture 112 (FIG. 12A) is allowed to freely passtherebetween. When the control suture 112 is properly positioned withinthe handle 132, the surgeon may allow the engagement mechanism 133 tomove back to the engaged position of FIG. 14A by releasing the trigger150.

Optionally, the engagement mechanism 133 includes a retention assembly170 for retaining the trigger 150 in the disengaged position of FIG. 14Bwherein the first and second elongate grippers 154A and 154B areseparated from one another and the control suture 112 is allowed tofreely pass therebetween. Although the retention assembly 170 is not anecessary component of the engagement mechanism 133, it increases theease-of-use of the delivery device 130 because the surgeon is notrequired to keep the trigger 150 manually depressed with one hand whilepulling the control suture 112 (FIG. 12A) through the delivery device130 with the other hand.

FIG. 15 is a perspective view of the trigger 150 illustrating theexemplary retention assembly 170 in accordance with the presentdisclosure. As illustrated in FIG. 15, the trigger 150 includes a distalend 171, a proximal end 172, and a side face 173. The exemplaryretention assembly 170 includes a coil spring 174 and a retention pin175 that are structured and sized to be received within a retention pinslot 176 within the side face 173 of the trigger 150. When assembled,the coil spring 174 is partially compressed between an inside end of theretention pin slot 176 and an adjacent end of the retention pin 175,thus biasing the retention pin 175 in the direction indicated by arrow178 away from the trigger 150.

FIGS. 16A and 16B are diagrams illustrating the operation of theretention assembly 170. Particularly, FIG. 16A is a cross-sectionaldistal end view of the trigger 150 illustrating the trigger in theengaged position wherein the first and second elongate grippers 154A and154B are in contact with one another as previously illustrated in FIG.14A. In the engaged position, the retention pin 175 is biased toward andslidable against an internal surface 180 of the handle 132.

FIG. 16B is a cross-sectional distal end view of the trigger 150illustrating the trigger in the disengaged position wherein the firstand second elongate grippers 154A and 154B are separated from oneanother to allow the control suture 112 to pass therebetween. As thetrigger 150 is being actuated from the engaged position of FIG. 16A tothe disengaged position of FIG. 16B, the retention pin 175 slidesagainst the internal surface 180 of the handle 132 and “snaps” into amating slot 182 in the handle 132 due to the outwardly directed springforce from the coil spring 174 to lock the trigger 150 in the disengagedposition. As illustrated in FIG. 16B, when the retention pin 175 snapsinto the mating slot 182, it pushes a push button 184 outwardly suchthat the push button 184 protrudes from the handle 132. With the trigger150 locked in the disengaged position, the surgeon may insert a stylettool through the handle lumen 148 and toward the cone-shaped housing 136to grasp and pull the control suture 112 (FIG. 12A) back through thehandle of the delivery device 130. Once the control suture 112 has beenpulled through the handle 132 of the delivery device 130, the surgeonmay once again move the engagement mechanism 133 to the engaged positionby pressing the push button 184 in the direction indicated by arrow 186.Pressing the push button 184 in this direction releases the retentionpin 175 from the mating slot 182 causing the trigger 150 to pivot backto the engaged position illustrated in FIG. 14A due to the force of thetorsion spring 156 biasing the trigger 150 to the engaged position aspreviously discussed.

Those of ordinary skill in the art will appreciate that the retentionassembly 170 has been illustrated and described as being positionedadjacent to the first handle section 147A merely for purposes of exampleand not limitation. Thus, in alternative embodiments the position of theretention assembly 170 may be modified, such as by positioning theretention assembly on an opposing side of the trigger 150 adjacent tothe second handle section 147B, without departing from the intendedscope of the present disclosure.

As will be appreciated by those of ordinary skill in the art, numerousother engagement mechanisms and retention assemblies are possible andwithin the intended scope of the present disclosure. Thus, any suitablemechanical engagement means that is movable between an engaged positionand a disengaged position to allow a suture to be pulled through thehandle and locked therein may be used without departing from theintended scope of the present disclosure.

FIG. 17 is a side view of a stylet tool 200 designed to be used inconjunction with the delivery device 130 (FIG. 13A) of the presentdisclosure. As illustrated in FIG. 17, the stylet tool 200 includes aflexible hook portion 202 at a distal end, a handle portion 204 at aproximal end, and an elongate main body 206 extending therebetween. Aswill be appreciated by those of ordinary skill in the art, the hookportion 202 is designed to grasp one or more control sutures 112 (FIG.12A) when the stylet tool 200 is inserted through the delivery device130 as will hereinafter be explained.

Now that embodiments of a crimping tool and a delivery device inaccordance with the present disclosure have been set forth in detail,methods of using the crimping tool and delivery device to crimp astented heart valve and deliver the heart valve to a patient will bedescribed. More particularly, depending on the preference of the surgeonin operation, the stented heart valve 100 may (FIG. 12A) be loaded intothe cone-shaped housing 136 of the delivery device 130 (FIG. 13A) inseveral different ways.

In a first embodiment of loading a stented heart valve into a deliverydevice in accordance with the present disclosure, the stented heartvalve 100 (FIG. 12A) is initially placed in chilled ice water so thatthe support stent 108 (FIG. 12B) becomes malleable. As will beappreciated by those of ordinary skill in the art, any suitable coolingmeans may be used to chill the support stent 108 to make it malleablewithout departing from the intended scope of the present disclosure.Once the support stent 108 has been cooled and becomes malleable, thestented heart valve 100 is positioned within the chamber 50 of thecrimping tool 10 with the compression assembly 12 in the uncrimpedposition as illustrated in FIG. 18. More particularly, the stented heartvalve 100 is inserted into the chamber 50 such that the inflow end 102is positioned adjacent to the back plate 23 and the outflow end 104 ispositioned adjacent to the access aperture 26. As further illustrated inFIG. 18, the control suture 112 is positioned such that is extendsthrough the outflow end 104 of the stented heart valve 100 and outsideof the crimping tool 10.

Next, as illustrated in FIG. 19, the actuation lever 16 of the crimpingtool 10 is moved in the clockwise direction 24B to radially crimp thestented heart valve 100 within the chamber 50. Once the stented heartvalve 100 has been fully crimped, the lever lock 18 may be moved fromthe unlocked position of FIG. 18 to the locked position of FIG. 19. Aspreviously discussed, moving the lever lock 18 to the locked positionprevents the unintentional expansion of the compression assembly 12 andthe stented heart valve 100 positioned therein from the crimped positionback toward the uncrimped position.

Once the stented heart valve 100 has been crimped within the chamber 50,the cone-shaped housing 136 of the delivery device 130 may be alignedwith the chamber 50 such that the cone-shaped lumen 138 is incommunication with the interior of the chamber as illustrated in FIG.20. Then, the surgeon may slide the delivery device holder 20horizontally such that the seat member 19 is aligned with the centeraxis of the access aperture 26 as previously discussed in detail withregard to FIG. 5. With the seat member 19 of the delivery device holder20 aligned with the access aperture, the delivery device 130 may then beengaged with the seat member 19 as illustrated in FIG. 21.

To assist with the alignment of the cone-shaped housing 136 of thedelivery device 130 with the chamber 50, each of the bars 34 of thecompression assembly 12 may include a recess 210 in the front face 70 asillustrated in FIG. 22. The plurality of recesses 210 together form asubstantially circular stepped region that is structured to mate withand receive a distal edge 212 of the cone-shaped housing 136. Inaddition to assisting with the alignment of the cone-shaped housing 136and the chamber 50, the stepped region formed by the plurality ofrecesses 210 also helps to maintain secure engagement between thedelivery device 130 and the seat member 19 of the delivery device holder20.

Next, an elongate cylindrical pusher tool 220 may be inserted through anaperture 222 in the back plate 23 of the crimping tool housing 14 asillustrated in FIG. 23 to manually push the crimped stented heart valve100 into the cone-shaped housing 136 of the delivery device 130. Becausethe length L2 of the cone-shaped housing 136 is slightly less than thelength L1 of the stented heart valve 100, a small portion of the inflowend 102 of the stented heart valve remains outside the cone-shapedhousing 136. The exposed portion of the stented heart valve 100 incombination with the cone-shape of the housing 136 allows the surgeon tovisualize correct anatomical placement of the heart valve in the aorticannulus. As will be appreciated by those of ordinary skill in the art,care should be taken to ensure that the tail ends of the control suture112 (hidden in FIG. 23), which may be tied or otherwise attachedtogether to form a continuous loop, are exposed at the outflow end 104(FIG. 12A) of the stented heart valve 100 and positioned next to thecentral passage 144 (FIG. 13A) of the cone-shaped housing 136. Theflexible hook portion 202 (FIG. 17) of the stylet tool 200 is theninserted through the handle lumen 148 (FIG. 13A) and positioned throughthe shaft lumen 146 (FIG. 13A) and the central passage 144 of thecone-shaped housing 136. The control suture 112 is then grasped by theflexible hook portion 202 within the cone-shaped housing 136. With thetrigger 150 (FIG. 14A) depressed such that the engagement mechanism 133(FIG. 14A) is in the disengaged position, the stylet tool 200 is pulledback through the shaft lumen 146 and the handle lumen 148 to thread thecontrol suture 112 through the delivery device 130. The surgeon thenmanipulates the engagement mechanism 133 back to the engaged position tograsp and lock the control suture 112 in place.

As best seen in FIG. 24, the delivery device 130 locks and tensions thecontrol suture 112 in a taut position by engagement between the firstand second elongate grippers 154A and 154B. As will be appreciated bythose of ordinary skill in the art, the tensioning of the control suture112 maintains the stented heart valve 100 (FIG. 23) in the radiallycrimped configuration throughout the deployment of the stented heartvalve into the aortic annulus until the tension is released. As willfurther be appreciated by those of ordinary skill in the art, althoughthe engagement mechanism 133 has been illustrated in the “fully” engagedand “fully” disengaged positions, the surgeon may manipulate theengagement mechanism 133 to a “partially” engaged position wherein thefirst and second elongate grippers 154A and 154B maintain at least sometension on the control suture 112 but also allow the control suture 112to slide therebetween in a controlled manner. This allows the surgeon tore-expand the stented heart valve in a controlled manner duringdeployment within a patient as will be discussed in further detail tofollow.

Another method of loading a stented heart valve into a delivery devicein accordance with the present disclosure is generally similar to thefirst exemplary method described above with regard to FIGS. 18-24.However, instead of threading the control suture 112 through thedelivery device 130 after the stented heart valve 100 has been crimpedand pushed into the cone-shaped housing 136, the control suture 112 isthreaded partially through the delivery device and locked by theengagement mechanism 133 prior to pushing the stented heart valve intothe cone-shaped housing 136. Once the crimped stented heart valve hasbeen pushed into the cone-shaped housing 136, the excess length of thecontrol suture 112 may be pulled through the handle lumen 148 and onceagain grasped by the engagement mechanism 133 so that the control suture112 is taut. As will be appreciated by those of ordinary skill in theart, the initial threading of the control suture 112 through thedelivery device 130 may be performed either before of after the stentedheart valve has been crimped.

Another embodiment of loading a stented heart valve into a deliverydevice 130, the flexible hook portion 202 of the stylet tool 200 isfirst inserted through the handle lumen 148 and positioned through theshaft lumen 146 and the central passage 144 of the cone-shaped housing136. The control suture 112 is then grasped by the flexible hook portion202 within the cone-shaped housing 136. With the trigger 150 depressedsuch that the engagement mechanism 133 is in the disengaged position,the stylet tool 200 is pulled back through the shaft lumen 146 and thehandle lumen 148 to thread the control suture 112 through the deliverydevice 130. The surgeon then manipulates the engagement mechanism 133back to the engaged position to grasp and lock the control suture 112 inan initial position in which the stented heart valve 100 hangs outsidethe cone-shaped housing 136 as best seen in FIG. 25. The stented heartvalve 100 is then placed in chilled ice water so that the support stent108 becomes malleable. Once again, those of ordinary skill in the artwill appreciate that any suitable cooling means may be used to chill thesupport stent 108 to make it malleable without departing from theintended scope of the present disclosure.

Once the support stent 108 has been cooled and becomes malleable, thestented heart valve 100 is positioned within the chamber 50 of thecrimping tool 10, and the heart valve 100 is crimped by actuating theactuation lever 16 as previously described. The cone-shaped housing 136of the delivery device 130 may then be aligned with the chamber 50 suchthat the cone-shaped lumen 138 is in communication with the interior ofthe chamber, and the surgeon may slide the delivery device holder 20horizontally such that the seat member 19 is aligned with the center ofthe access aperture 26 in the housing 14. With the seat member 19 of thedelivery device holder 20 aligned with the access aperture 26, thedelivery device 130 may then be positioned within the seat member 19. Aswill be appreciated by those of ordinary skill in the art, the deliverydevice holder 20 may alternatively be aligned with the access apertureand the delivery device 130 positioned therein prior to crimping thestented heart valve 100.

Next, the elongate cylindrical pusher tool 220 may be inserted throughthe aperture 222 in the back plate 23 of the crimping tool housing 14 aspreviously described to manually push the crimped stented heart valve100 into the cone-shaped housing 136 of the delivery device 130. Onceagain, because the length L2 of the cone-shaped housing 136 is slightlyless than the length L1 of the stented heart valve 100, a small portionof the inflow end 102 of the stented heart valve remains outside thecone-shaped housing 136. With the engagement mechanism 133 in thedisengaged position, the surgeon then manually pulls the remaininglength of the control suture 112 through the shaft lumen 146 and handlelumen 148. The engagement mechanism 133 is then actuated back to theengaged position to once again grasp and apply tension to the controlsuture 112 to maintain the stented heart valve 100 in the radiallycrimped configuration during delivery of the valve.

As will be appreciated by those of ordinary skill in the art, theforegoing represent three stent crimping and loading methods inaccordance with the present disclosure. However, numerous other methodsare possible and within the intended scope of the present disclosure.Further, the number and order of steps described with regard to thethree exemplary methods may be altered as will be appreciated by thoseof ordinary skill in the art.

The stent crimping and loading methods have been described withreference to the crimping tool 10 and the delivery device 130 merely forpurposes of example and not limitation. Thus, the methods in accordancewith the present disclosure may be performed using various othercrimping tool and/or delivery device embodiments without departing fromthe intended scope of the present disclosure.

FIG. 26 is a perspective view of the delivery device 130 with thestented heart valve 100 loaded therein with the inflow end 102 partiallyexposed. After the stented heart valve 100 has been crimped and loadedinto the delivery device 130 as illustrated in FIG. 26 using anysuitable crimping and loading method, the delivery device 130 may bepositioned adjacent to the desired implantation site for delivery of thecrimped stented heart valve 100 within the implantation site.

In one embodiment as discussed above, the delivery device 130 of thepresent native valve may be used to deliver a crimped stented heartvalve to an aortic annulus. In order to access the disclosure annulus,the patient may be put on bypass and the aorta at least partiallytransected. Then, as illustrated in the partial cross-sectional view ofFIG. 27A the surgeon positions the delivery device 130 within thedisclosure annulus 230, pushing aside the native leaflets 232, such thatthe exposed inflow end 102 is substantially aligned with the inflowannulus of the native valve. As will be appreciated by those of ordinaryskill in the art, warm bodily fluids cause the exposed portion of thestented heart valve 100, i.e. the inflow end 102, to start to expand tothe “remembered” shape as further illustrated in FIG. 27A. Alternativelyor in addition, the surgeon may apply a warm solution to theimplantation site to promote re-expansion of the stented heart valve100, such as a warm saline solution.

As the stented heart valve 100 starts to expand, the delivery device 130may be retracted as illustrated in FIG. 27B to expose an additionallength of the inflow end 102 of the stented heart valve 100. As tensionis slowly released from the control suture 112 by releasing theengagement mechanism 133 from the engaged position in a controlledmanner, the inflow end 102 of the stented heart valve 100 completelyexpands in the native annulus 230 where it friction fits and seals intoplace. The delivery device 130 is then slowly removed from the nativeannulus 230 which exposes and deploys the remainder of the stented heartvalve 100 in the native annulus 230 as illustrated in FIG. 27C. As willbe appreciated by those of ordinary skill in the art, once the stentedheart valve 100 is fully expanded within the native annulus 230, thecontrol suture 112 may be manually removed from the stented heart valvein any suitable manner as it is no longer needed.

Those of ordinary skill in the art will appreciate that heart valvedelivery devices in accordance with the present disclosure may be usedfor the delivery of many types of valves, including both mitral andtricuspid valves. The cone-shape of the housing in combination with anexposed inflow end portion of the stented valve permits the surgeon tovisualize placement of the delivery device and the stented valve in theanatomically correct position regardless of where the stented valve isimplanted. Thus, delivery of a stented heart valve within the disclosureannulus has been described merely for purposes of example and notlimitation.

1. A delivery device for a stented heart valve comprising: a handle; anelongate shaft extending from a distal end of the handle; and a conicalhousing having a proximal end coupled to the elongate shaft and an opendistal end, the conical housing having a conical lumen therein with afirst internal diameter adjacent to the proximal end of the conicalhousing and a larger second internal diameter adjacent to the opendistal end of the conical housing.
 2. The delivery device of claim 1,wherein the elongate shaft includes a shaft lumen structured to providea pathway between the conical lumen of the conical housing and aninterior of the handle.
 3. The delivery device of claim 2, wherein theconical housing is formed from a transparent material.
 4. The deliverydevice of claim 2, wherein the handle includes a handle lumen in aproximal end thereof.
 5. The delivery device of claim 4, wherein thehandle lumen is substantially aligned with the shaft lumen.
 6. Thedelivery device of claim 5 further comprising an engagement mechanismoperably coupled to the handle, the engagement mechanism movable betweenan engaged position and a disengaged position.
 7. The delivery device ofclaim 6, wherein the engagement mechanism includes a trigger extendingoutside of the handle for moving the engagement mechanism between theengaged position and the disengaged position.
 8. The delivery device ofclaim 7, wherein the trigger is pivotally coupled to a pivot pinattached to the handle.
 9. The delivery device of claim 8, wherein theengagement mechanism includes a first elongate gripper on the triggerand a second elongate gripper on the handle.
 10. The delivery device ofclaim 9, wherein the second elongate gripper is fixed relative to thehandle and the first elongate gripper is movable relative to the secondelongate gripper between an engaged position and a disengaged position.11. The delivery device of claim 10, wherein the first and secondelongate grippers are cylindrical in shape.
 12. The delivery device ofclaim 10 further comprising at least one torsion spring operably coupledto the trigger, the torsion spring biasing the engagement mechanism inthe engaged position.
 13. The delivery device of claim 12 furthercomprising a retention assembly operable to lock the engagementmechanism in the disengaged position.
 14. The delivery device of claim13, wherein the retention assembly includes a coil spring and aretention pin structured to be received within a retention pin slot inthe trigger.
 15. The delivery device of claim 14, wherein the handleincludes a mating slot that is structured to receive the retention pinto lock the engagement mechanism in the disengaged position.
 16. Thedelivery device of claim 15 further comprising a push button slidablypositioned within the mating slot, wherein actuating the push buttonmoves the engagement mechanism from the disengaged position back to theengaged position.
 17. The delivery device of claim 1 in combination witha stented heart valve, the stented heart valve comprising: a supportstent having an inflow end and an outflow end; a replacement heart valvepositioned within and coupled to the support stent; a cloth covering onthe inflow end of the support stent; and a control suture sewn into thecloth covering.
 18. The delivery device of claim 17, wherein the clothcovering is formed from polyester.
 19. The delivery device of claim 17,wherein the support stent is formed from Nitinol.
 20. The deliverydevice of claim 17, wherein the support stent includes a plurality ofsupport posts, each of the support posts including a slot that isstructured to receive a commissural tab for coupling the replacementheart valve to the support stent.
 21. The delivery device of claim 20,wherein the control suture is threaded through a plurality of sutureapertures in the cloth covering.
 22. The delivery device of claim 21,wherein the cloth covering includes two suture apertures between eachpair of adjacent support posts.
 23. The delivery device of claim 17,wherein terminal ends of the control suture are tied together to form acontinuous control suture loop.
 24. A method of loading a stented heartvalve into a delivery device comprising: receiving a delivery device,the delivery device including a handle on a proximal end, a housing on adistal end, and a shaft extending therebetween; crimping a stented heartvalve with a crimping tool, the stented heart valve including a radiallycompressible support stent, a replacement valve, and a control suture;pushing the crimped stented heart valve into the housing of the deliverydevice; pulling the control suture through the shaft and the handle ofthe delivery device; and engaging the control suture with an engagementmechanism operably coupled to the handle of the delivery device to applytension to the control suture such that the crimped stented heart valveis retained within the housing.
 25. The method of claim 24, wherein thehousing of the delivery device is generally conical in shape andincludes a conical lumen therein, the conical lumen defined by a firstinternal diameter at a first end of the housing adjacent to the shaftand a larger second internal diameter at an open second end of thehousing.
 26. The method of claim 25, wherein the step of pulling thecontrol suture through the shaft further comprises inserting a stylettool through a lumen in the shaft in a first direction, grasping thecontrol suture, and pulling the stylet tool in a second directionopposite the first direction.
 27. The method of claim 26, wherein theengagement mechanism is movable between an engaged position and adisengaged position, the control suture being pulled through the shaftand the handle of the delivery device when the engagement mechanism isin the disengaged position, and the engagement mechanism applyingtension to the control suture in the engaged position.
 28. The method ofclaim 27, wherein the engagement mechanism includes a trigger extendingoutside of the housing for moving the engagement mechanism between theengaged position and the disengaged position.
 29. The method of claim28, wherein the engagement mechanism includes a first elongate gripperattached to the trigger and a second elongate gripper attached to thehandle, the first elongate gripper movable relative to the secondelongate gripper between an engaged position and a disengaged position.30. The method of claim 29, wherein the engagement mechanism includes atleast one torsion spring operably coupled to the trigger, the torsionspring biasing the trigger in the engaged position.
 31. The method ofclaim 30, wherein the delivery device includes a retention assemblyoperable to lock the engagement mechanism in the disengaged position.32. The method of claim 27 further comprising the step of cooling thestented heart valve to make the support stent malleable prior tocrimping the stented heart valve with the crimping tool.
 33. The methodof claim 32, wherein the step of cooling the stented heart valvecomprises placing the stented heart valve in chilled water.
 34. Themethod of claim 32, wherein the step of pulling the control suturethrough the shaft and the handle of the delivery device is performedafter the crimped stented heart valve has been pushed into the housingof the delivery device.
 35. The method of claim 32, wherein the controlsuture is partially threaded through the shaft and the handle of thedelivery device prior to pushing the crimped stented heart valve intothe housing of the delivery device.
 36. The method of claim 32, whereinthe control suture is partially threaded through the shaft and thehandle of the delivery device prior to crimping the stented heart valvewith the crimping tool.
 37. The method of claim 32, wherein the stentedheart valve is pushed into the housing of the delivery device such thatan inflow end of the stented heart valve is positioned substantiallyadjacent to the open second end of the housing.
 38. The method of claim37, wherein an axial length of the conical lumen of the housing is lessthan an axial length of the stented heart valve such that at least aportion of the inflow end of the stented heart valve extends outside ofthe open second end of the housing.
 39. A method of delivering a stentedheart valve to an implantation site comprising: receiving a deliverydevice including a conical housing, the conical housing having a conicallumen therein with a first internal diameter adjacent to a proximal endof the conical housing and a larger second internal diameter adjacent toa distal end of the conical housing; loading a crimped stented heartvalve into the conical housing such that an inflow end of the stentedheart valve extends outside of the housing past the distal end;positioning the conical housing at an implantation site; allowing theinflow end of the stented heart valve to expand within the implantationsite; and manipulating the delivery device to expose additional portionsof the stented heart valve to allow for expansion within theimplantation site.
 40. The method of claim 39, wherein the stented heartvalve includes a control suture that is engaged by an engagementmechanism of the delivery device to retain the crimped stented heartvalve within the conical housing.
 41. The method of claim 40, whereinthe engagement mechanism is movable between an engaged position and adisengaged position to control tension placed upon the control suture.42. The method of claim 41, wherein the engagement mechanism includes atrigger for moving the engagement mechanism between the engaged positionand the disengaged position.
 43. The method of claim 42, wherein thestep of manipulating the delivery device to expose additional portionsof the stented heart valve comprises moving the engagement mechanismfrom the engaged position to the disengaged position in a controlledmanner while retracting the delivery device from the implantation site.44. The method of claim 40 further comprising the step of manuallywarming the implantation site to promote re-expansion of the stentedheart valve.
 45. The method of claim 40, wherein the stented heart valvefurther comprises a cloth covering on the inflow end, the control suturebeing sewn into the cloth covering.
 46. The method of claim 40, whereinthe implantation site is an aortic annulus.
 47. The method of claim 40,wherein the step of loading a crimped stented heart valve comprises:crimping the stented heart valve with a crimping tool; pushing thecrimped stented heart valve into the conical housing of the deliverydevice; and pulling the control suture through a shaft and a handle ofthe delivery device.
 48. The method of claim 47 further comprising thestep of cooling the stented heart valve prior to crimping to make thestented heart valve malleable.